BIOSAPIEN - THE REVOLUTIONARY CANCER PLATFORM DEVELOPER - ANNOUNCES TWO, WORLD-CLASS US MANUFACTURING PARTNERS: ROSWELL PARK AND BA SCIENCES

SAN DIEGO, July 1, 2026 /PRNewswire/ -- BioSapien, the pioneering biotech company, announces two world-class US manufacturing partners, ahead of imminent Phase I clinical trials for MediChip™, its revolutionary localised cancer drug delivery platform.

BioSapien has been working with Roswell Park Comprehensive Cancer Center ("Roswell Park") - an iconic name in US cancer care; and BA Sciences – a provider of state of-the-art analytical services - with each playing vital roles in the MediChip™ manufacturing process.

Ahead of imminent Phase I clinical trials in the UAE, BioSapien has completed the first clinical batch of production of its GMP grade MediChips, at Roswell Park. Production took place in an ISO-7 cleanroom space within the Roswell Park GMP Engineering & Cell Manufacturing (GEM) Facility leased by Roswell Park to BioSapien – the first external company Roswell Park has ever rented out cleanroom space to. Further production of clinical MediChips and intermediates will take place at Roswell Park.

Roswell Park has also provided support and documentation for BioSapien's US Investigational New Drug (IND) submission to the US Food & Drug Administration.

BA Sciences has validated all GMP analytics required by BioSapien for a clinical product, and carried out those analytics on the produced MediChips. Other activity by BA Sciences includes stability studies to confirm the longevity of MediChip™ and to extend its shelf life.

Dr. Khatija Ali, CEO and Founder of BioSapien, said:

"I am delighted to announce that BioSapien is Phase I clinical trial ready, from a production perspective, and our first clinical batch has now arrived in the UAE. We are all judged by the company we keep, and so we are honored to work with two stellar names in Roswell Park and BA Sciences. They have been crucial cogs in our manufacturing process, and we thank them for joining us on our journey to making localised cancer treatment the global standard."

Roswell Park is an iconic name in US cancer care. Founded in 1898 as the country's first integrated cancer research and treatment center, and operating from a 28-acre campus near downtown Buffalo, NY, it sets international standards via its role as a founding member of the National Comprehensive Cancer Network. Backed by Empire State Development, the umbrella organization for New York's two principal economic development public-benefit corporations, its 20 'clean rooms' are ideal for fast-tracking Research & Development.

Founded in 1987, and based in Salem, NH - BA Sciences is a cGMP compliant, FDA/DEA registered, ISO/IEC-17025:2017 certified analytical laboratory, and is a trusted provider of high-quality analytical testing services to life science companies worldwide.

Yeong Christopher Choi, PhD, MBA, Senior Vice President of Industry Partnerships at Roswell Park Comprehensive Cancer Center, commented:

"We're deeply proud to have supported BioSapien in advancing MediChips through late preclinical development. Our work with BioSapien is exactly the type of collaboration we envisioned when we opened our expanded Roswell Park GMP Engineering & Cell Manufacturing Facility in 2025. We have the expertise, capacity and responsiveness to help researchers and partner companies of all sizes to move smart innovations forward quickly and effectively."

Erica Welker, Senior Director - Western Region at BA Sciences, said:

"All of us at BA Sciences have greatly enjoyed our collaboration with the BioSapien Team. BA is excited to continue our contribution and common goal toward the success of MediChip."

Angela Hutter, Manager of Client Services at BA Sciences, commented:

"BA Sciences provides comprehensive analytical support for the MediChip program, including testing of the final drug product as well as the individual Spool components used in its manufacture. BA Sciences developed and validated IVRT and Assay/Impurities methods and continues to perform routine release and stability testing to support the product through its early clinical phases."

MediChip™, is a drug delivery, 3D-printed, slow-release delivery platform attachable to any tissue with minimal systemic side effects.

Local delivery means more of the drug stays in the tumor microenvironment (i.e., where the tumor is located) to aid more efficient oncology, such as downsized tumors, alleviate symptoms and prevent potentially life-altering surgeries. Local delivery also requires fewer quantities of drugs to be used while maintaining safety.

Notes to Editors

About BioSapien

BioSapien is the pioneering biotech company behind MediChip™, a revolutionary localised cancer treatment platform, attachable to any tissue with minimal systemic side effects. Local delivery means more of the drug stays in the tumor microenvironment (i.e., where the tumor is located) to aid more efficient oncology, such as downsized tumors, alleviate symptoms and prevent potentially life-altering surgeries.

BioSapien is set to commence imminent Phase I clinical trials for MediChip™ in the UAE - concentrating initially on colorectal cancer patients, with scope to subsequently branch out to other cancers (pancreatic, lung), and non-cancer indications.

About Roswell Park

From the world's first chemotherapy research to the PSA prostate cancer biomarker, Roswell Park Comprehensive Cancer Center generates innovations that shape how cancer is detected, treated and prevented worldwide.

The Roswell Park team of 4,000+ makes compassionate, patient-centered cancer care and services accessible across New York State and beyond. Rated "Exceptional" by the National Cancer Institute, Roswell Park, founded in 1898, was one of the first NCI-designated comprehensive cancer centers in the country and remains the only one in Upstate New York.

To learn more about Roswell Park Comprehensive Cancer Center and the Roswell Park Care Network, visit www.roswellpark.org

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SOURCE BioSapien Inc